[Congressional Record Volume 155, Number 85 (Tuesday, June 9, 2009)]
[Senate]
[Pages S6371-S6380]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. BAUCUS (for himself and Mr. Conrad):
  S. 1213. A bill to amend title XI of the Social Security Act to 
provide for the conduct of comparative effectiveness research and to 
amend the Internal Revenue Code of 1986 to establish a Patient-Centered 
Outcomes Research Trust Fund, and for other purposes; to the Committee 
on Finance.
  Mr. BAUCUS. Mr. President, last year, America spent $2.4 trillion on 
health care. That is 1/6 of our economy. Yet we ranked last among major 
industrialized nations in the Commonwealth Fund's National Scorecard on 
Health System Performance, which ranks the number of deaths that could 
be prevented before age 75 through effective health care.
  Some analysts estimate that as much as 30 percent of our spending is 
for ineffective, redundant, or inappropriate care. That's care that 
does nothing to improve the health of Americans.
  Our system also leaves nearly 50 million Americans without health 
coverage and 25 million more with inadequate coverage. Most 
bankruptcies and foreclosures in America are related to medical costs.
  Our system needs reform.
  Today, along with Senator Conrad, the Chairman of the Budget 
Committee, I am proud to introduce a bill that would improve health 
care in America by helping doctors and patients to make better, more-
informed health care decisions.
  This legislation would increase the chances that Americans receive 
the right care. This bill would provide for research that can help 
physicians and patients know more about what works best in medicine, 
and what does not.
  Some patients, receive medical treatments that work well. Some 
patients receive treatments that do not. In many cases, doctors simply 
don't have enough reliable evidence to decide which treatments are best 
for which patients.
  Rapid innovation and advancements in medicine have led to an ever-
changing array of new and sometimes expensive technologies. The age of 
personalized medicine and genetic engineering will provide even more 
choices for patients and their physicians. Indeed, both patients and 
physicians can face great difficulty in choosing among treatment 
options.
  Patients and physicians need more credible information about how 
treatments for a specific condition compare to each other. Today, the 
vast majority of medical information shows how treatments work compared 
to placebos. Most medical information does not show how treatments work 
compared to each other.
  For example, men with prostate cancer have a choice among 3 common 
treatments surgery, radiation, and chemotherapy. Each approach yields 
different outcomes in terms of survival, ability to return to work, and 
other measures of quality of life.
  Comparative effectiveness research would compare each approach in a 
systematic way. That way, doctors and patients would have more 
information about how options work, and for whom. The bill that I 
introduce today would do just that.
  This bill would facilitate comparisons across a broad spectrum of 
health care interventions and health care strategies that are used to 
prevent, treat, diagnose and manage health conditions. By evaluating 
and comparing what works best, patients and providers can make more 
informed decisions about care.
  More specifically, this bill would create a nonprofit institute that 
would be responsible for setting national health care research 
priorities. The institute, called the Patient-Centered Outcomes 
Research Institute, would be a private

[[Page S6372]]

entity. It would be governed by a multi-stakeholder, public-private 
sector Board of Governors. It would not be an agency of the Federal 
Government.
  Keeping the Institute a private, nonprofit entity would shelter it 
from potential political influence from both the executive and 
legislative branches of Government. The independence and expertise of 
the Institute would result in more credible and more useful research 
for Americans.
  The Institute would set national priorities for comparative 
effectiveness research and facilitate studies that would help to answer 
the most pressing questions about what works, and what doesn't.
  The Institute would have the authority to contract with experienced 
Federal agencies--such as the National Institutes of Health and the 
Agency for Health Care Research and Quality, or with private 
researchers--to carry out the actual research. The Institute would also 
be responsible for disseminating the findings of the research in ways 
that make sense to both patients and providers.
  The Institute's work would not happen behind closed doors. The bill 
would provide opportunities for public input and scientific review of 
the integrity of the research being conducted. The Institute's meetings 
would be accessible to the public, and open forums would help to 
solicit and obtain input on the Institute's activities and agenda. 
Also, public comment periods would be made available to discuss 
research findings.
  The Institute's work would benefit all Americans who receive health 
care. So both public and private payers would fund the Institute. After 
an initial investment from general revenues, the Institute would be 
funded by an all-payer system, drawing from both public and private 
sources.
  Comparative effectiveness research would not be the ultimate decision 
maker. Instead, it would provide an additional tool to improve health 
quality. The Institute would be a health care resource, a scientific 
entity, a source of knowledge, and a provider of information.
  According to the Institute of Medicine, this research would provide 
better evidence--objective information--so that doctors and patients 
could make better decisions.
  If we are truly to reform our health care system, then we must get 
more evidence into the hands of the people making medical decisions. 
This research is not only about reducing health care costs. It is 
focused on addressing significant gaps in knowledge.
  It is not just the academics and economists who agree. Patient 
advocates like the National Breast Cancer Coalition, provider groups 
like the American Medical Association, and consumer groups like AARP 
can see the benefits of this research quite clearly. They have all 
extended their support.
  The American Recovery and Reinvestment Act made a significant 
investment towards this type of research. But that was just a first 
step. We must ensure that this research will be sustained in the years 
to come.
  From cars to toasters, Americans are able to readily view and 
evaluate information about the quality and effectiveness of so many of 
the items that they buy. It seems only logical that they should have 
information on what works and what does not when it comes to their 
health, especially with one in every 6 of this country's dollars leing 
spent on health care.
  It is time for Americans and their doctors to be wield the world's 
most advanced science, so that the most personal health care decisions, 
like so many of the other decisions we make, are made with access to 
the best available information.
  I urge my colleagues to support this common-sense measure.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 1213

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Patient-Centered Outcomes 
     Research Act of 2009''.

     SEC. 2. COMPARATIVE EFFECTIVENESS RESEARCH.

       (a) In General.--Title XI of the Social Security Act (42 
     U.S.C. 1301 et seq.) is amended by adding at the end the 
     following new part:

              ``Part D--Comparative Effectiveness Research


                  ``comparative effectiveness research

       ``Sec. 1181.  (a) Definitions.--In this section:
       ``(1) Board.--The term `Board' means the Board of Governors 
     established under subsection (f).
       ``(2) Comparative clinical effectiveness research.--
       ``(A) In general.--The term `comparative clinical 
     effectiveness research' means research evaluating and 
     comparing the clinical effectiveness, risks, and benefits of 
     2 or more medical treatments, services, and items described 
     in subparagraph (B).
       ``(B) Medical treatments, services, and items described.--
     The medical treatments, services, and items described in this 
     subparagraph are health care interventions, protocols for 
     treatment, care management, and delivery, procedures, medical 
     devices, diagnostic tools, pharmaceuticals (including drugs 
     and biologicals), and any other strategies or items being 
     used in the treatment, management, and diagnosis of, or 
     prevention of illness or injury in, patients.
       ``(3) Comparative effectiveness research.--The term 
     `comparative effectiveness research' means research 
     evaluating and comparing the implications and outcomes of 2 
     or more health care strategies to address a particular 
     medical condition for specific patient populations.
       ``(4) Conflicts of interest.--The term `conflicts of 
     interest' means associations, including financial and 
     personal, that may be reasonably assumed to have the 
     potential to bias an individual's decisions in matters 
     related to the Institute or the conduct of activities under 
     this section.
       ``(5) Institute.--The term `Institute' means the `Patient-
     Centered Outcomes Research Institute' established under 
     subsection (b)(1).
       ``(b) Patient-Centered Outcomes Research Institute.--
       ``(1) Establishment.--There is authorized to be established 
     a nonprofit corporation, to be known as the ``Patient-
     Centered Outcomes Research Institute'' which is neither an 
     agency nor establishment of the United States Government.
       ``(2) Application of provisions.--The Institute shall be 
     subject to the provisions of this section, and, to the extent 
     consistent with this section, to the District of Columbia 
     Nonprofit Corporation Act.
       ``(3) Funding of comparative effectiveness research.--For 
     fiscal year 2010 and each subsequent fiscal year, amounts in 
     the Patient-Centered Outcomes Research Trust Fund (referred 
     to in this section as the `PCORTF') under section 9511 of the 
     Internal Revenue Code of 1986 shall be available, without 
     further appropriation, to the Institute to carry out this 
     section.
       ``(c) Purpose.--The purpose of the Institute is to assist 
     patients, clinicians, purchasers, and policy makers in making 
     informed health decisions by advancing the quality and 
     relevance of evidence concerning the manner in which 
     diseases, disorders, and other health conditions can 
     effectively and appropriately be prevented, diagnosed, 
     treated, monitored, and managed through research and evidence 
     synthesis that considers variations in patient 
     subpopulations, and the dissemination of research findings 
     with respect to the relative clinical outcomes, clinical 
     effectiveness, and appropriateness of the medical treatments, 
     services, and items described in subsection (a)(2)(B).
       ``(d) Duties.--
       ``(1) Identifying research priorities and establishing 
     research project agenda.--
       ``(A) Identifying research priorities.--The Institute shall 
     identify national priorities for comparative clinical 
     effectiveness research, taking into account factors, 
     including--
       ``(i) disease incidence, prevalence, and burden in the 
     United States;
       ``(ii) evidence gaps in terms of clinical outcomes;
       ``(iii) practice variations, including variations in 
     delivery and outcomes by geography, treatment site, provider 
     type, and patient subgroup;
       ``(iv) the potential for new evidence concerning certain 
     categories of health care services or treatments to improve 
     patient health and well-being, and the quality of care;
       ``(v) the effect or potential for an effect on health 
     expenditures associated with a health condition or the use of 
     a particular medical treatment, service, or item;
       ``(vi) the effect or potential for an effect on patient 
     needs, outcomes, and preferences, including quality of life; 
     and
       ``(vii) the relevance to assisting patients and clinicians 
     in making informed health decisions.
       ``(B) Establishing research project agenda.--
       ``(i) In general.--The Institute shall establish and update 
     a research project agenda for comparative clinical 
     effectiveness research to address the priorities identified 
     under subparagraph (A), taking into consideration the types 
     of such research that might address each priority and the 
     relative value (determined based on the cost of conducting 
     such research compared to the potential usefulness of the 
     information produced by such research) associated with the 
     different types of research, and such other factors as the 
     Institute determines appropriate.

[[Page S6373]]

       ``(ii) Consideration of need to conduct a systematic 
     review.--In establishing and updating the research project 
     agenda under clause (i), the Institute shall consider the 
     need to conduct a systematic review of existing research 
     before providing for the conduct of new research under 
     paragraph (2)(A).
       ``(2) Carrying out research project agenda.--
       ``(A) Comparative clinical effectiveness research.--In 
     carrying out the research project agenda established under 
     paragraph (1)(B), the Institute shall provide for the conduct 
     of appropriate research and the synthesis of evidence, in 
     accordance with the methodological standards adopted under 
     paragraph (10), using methods, including the following:
       ``(i) Systematic reviews and assessments of existing 
     research and evidence.
       ``(ii) Primary research, such as randomized clinical 
     trials, molecularly informed trials, and observational 
     studies.
       ``(iii) Any other methodologies recommended by the 
     methodology committee established under paragraph (7) that 
     are adopted by the Board under paragraph (10).
       ``(B) Contracts for the management and conduct of 
     research.--
       ``(i) In general.--The Institute may enter into contracts 
     for the management and conduct of research in accordance with 
     the research project agenda established under paragraph 
     (1)(B) with the following:

       ``(I) Agencies and instrumentalities of the Federal 
     Government that have experience in conducting comparative 
     clinical effectiveness research, such as the Agency for 
     Healthcare Research and Quality, to the extent that such 
     contracts are authorized under the governing statutes of such 
     agencies and instrumentalities.
       ``(II) Appropriate private sector research or study-
     conducting entities that have demonstrated the experience and 
     capacity to achieve the goals of comparative effectiveness 
     research.

       ``(ii) Conditions for contracts.--A contract entered into 
     under this subparagraph shall require that the agency, 
     instrumentality, or other entity--

       ``(I) abide by the transparency and conflicts of interest 
     requirements that apply to the Institute with respect to the 
     research managed or conducted under such contract;
       ``(II) comply with the methodological standards adopted 
     under paragraph (10) with respect to such research;
       ``(III) take into consideration public comments on the 
     study design that are transmitted by the Institute to the 
     agency, instrumentality, or other entity under subsection 
     (i)(1)(B) during the finalization of the study design and 
     transmit responses to such comments to the Institute, which 
     will publish such comments, responses, and finalized study 
     design in accordance with subsection (i)(3)(A)(iii) prior to 
     the conduct of such research; and
       ``(IV) in the case where the agency, instrumentality, or 
     other entity is managing or conducting a comparative 
     effectiveness research study for a rare disease, consult with 
     the expert advisory panel for rare disease appointed under 
     paragraph (5)(A)(iii) with respect to such research study.

       ``(iii) Coverage of copayments or coinsurance.--A contract 
     entered into under this subparagraph may allow for the 
     coverage of copayments or co-insurance, or allow for other 
     appropriate measures, to the extent that such coverage or 
     other measures are necessary to preserve the validity of a 
     research project, such as in the case where the research 
     project must be blinded.
       ``(C) Review and update of evidence.--The Institute shall 
     review and update evidence on a periodic basis, in order to 
     take into account new research, evolving evidence, advances 
     in medical technology, and changes in the standard of care as 
     they become available, as appropriate.
       ``(D) Taking into account potential differences.--Research 
     shall--
       ``(i) be designed, as appropriate, to take into account the 
     potential for differences in the effectiveness of health care 
     treatments, services, and items as used with various 
     subpopulations, such as racial and ethnic minorities, women, 
     age, and groups of individuals with different comorbidities, 
     genetic and molecular sub-types, or quality of life 
     preferences; and
       ``(ii) include members of such subpopulations as subjects 
     in the research as feasible and appropriate.
       ``(E) Differences in treatment modalities.--Research shall 
     be designed, as appropriate, to take into account different 
     characteristics of treatment modalities that may affect 
     research outcomes, such as the phase of the treatment 
     modality in the innovation cycle and the impact of the skill 
     of the operator of the treatment modality.
       ``(3) Study and report on feasibility of conducting 
     research in-house.--
       ``(A) Study.--The Institute shall conduct a study on the 
     feasibility of conducting research in-house.
       ``(B) Report.--Not later than 5 years after the date of 
     enactment of this section, the Institute shall submit a 
     report to Congress containing the results of the study 
     conducted under subparagraph (A).
       ``(4) Data collection.--
       ``(A) In general.--The Secretary shall, with appropriate 
     safeguards for privacy, make available to the Institute such 
     data collected by the Centers for Medicare & Medicaid 
     Services under the programs under titles XVIII, XIX, and XXI 
     as the Institute may require to carry out this section. The 
     Institute may also request and, if such request is granted, 
     obtain data from Federal, State, or private entities, 
     including data from clinical databases and registries.
       ``(B) Use of data.--The Institute shall only use data 
     provided to the Institute under subparagraph (A) in 
     accordance with laws and regulations governing the release 
     and use of such data, including applicable confidentiality 
     and privacy standards.
       ``(5) Appointing expert advisory panels.--
       ``(A) Appointment.--
       ``(i) In general.--The Institute shall, as appropriate, 
     appoint expert advisory panels to assist in identifying 
     research priorities and establishing the research project 
     agenda under paragraph (1). Panels shall advise the Institute 
     in matters such as identifying gaps in and updating medical 
     evidence in order to ensure that the information produced 
     from such research is clinically relevant to decisions made 
     by clinicians and patients at the point of care.
       ``(ii) Expert advisory panels for primary research.--The 
     Institute shall appoint expert advisory panels in carrying 
     out the research project agenda under paragraph (2)(A)(ii). 
     Such expert advisory panels shall, upon request, advise the 
     Institute and the agency, instrumentality, or entity 
     conducting the research on the research question involved and 
     the research design or protocol, including the appropriate 
     comparator technologies, important patient subgroups, and 
     other parameters of the research, as necessary. Upon the 
     request of such agency, instrumentality, or entity, such 
     panels shall be available as a resource for technical 
     questions that may arise during the conduct of such research.
       ``(iii) Expert advisory panel for rare disease.--In the 
     case of a comparative effectiveness research study for rare 
     disease, the Institute shall appoint an expert advisory panel 
     for purposes of assisting in the design of such research 
     study and determining the relative value and feasibility of 
     conducting such research study.
       ``(B) Composition.--
       ``(i) In general.--An expert advisory panel appointed under 
     subparagraph (A) shall include individuals who have 
     experience in the relevant topic, project, or category for 
     which the panel is established, including--

       ``(I) practicing and research clinicians (including 
     relevant specialists and subspecialists), patients, and 
     representatives of patients; and
       ``(II) experts in scientific and health services research, 
     health services delivery, and evidence-based medicine.

       ``(ii) Inclusion of representatives of manufacturers of 
     medical technology.--An expert advisory panel appointed under 
     subparagraph (A) may include a representative of each 
     manufacturer of each medical technology that is included 
     under the relevant topic, project, or category for which the 
     panel is established.
       ``(6) Supporting patient and consumer representatives.--The 
     Institute shall provide support and resources to help patient 
     and consumer representatives on the Board and expert advisory 
     panels appointed by the Institute under paragraph (5) to 
     effectively participate in technical discussions regarding 
     complex research topics. Such support shall include initial 
     and continuing education to facilitate effective engagement 
     in activities undertaken by the Institute and may include 
     regular and ongoing opportunities for patient and consumer 
     representatives to interact with each other and to exchange 
     information and support regarding their involvement in the 
     Institute's activities. The Institute shall provide per diem 
     and other appropriate compensation to patient and consumer 
     representatives for their time spent participating in the 
     activities of the Institute under this paragraph.
       ``(7) Establishing methodology committee.--
       ``(A) In general.--The Institute shall establish a standing 
     methodology committee to carry out the functions described in 
     subparagraph (C).
       ``(B) Appointment and composition.--The methodology 
     committee established under subparagraph (A) shall be 
     composed of not more than 17 members appointed by the 
     Comptroller General of the United States. Members appointed 
     to the methodology committee shall be experts in their 
     scientific field, such as health services research, clinical 
     research, comparative effectiveness research, biostatistics, 
     genomics, and research methodologies. Stakeholders with such 
     expertise may be appointed to the methodology committee.
       ``(C) Functions.--Subject to subparagraph (D), the 
     methodology committee shall work to develop and improve the 
     science and methods of comparative effectiveness research by 
     undertaking, directly or through subcontract, the following 
     activities:
       ``(i) Not later than 2 years after the date on which the 
     members of the methodology committee are appointed under 
     subparagraph (B), developing and periodically updating the 
     following:

       ``(I) Establish and maintain methodological standards for 
     comparative clinical effectiveness research on major 
     categories of interventions to prevent, diagnose, or treat a 
     clinical condition or improve the delivery of care. Such 
     methodological standards shall provide specific criteria for 
     internal validity, generalizability, feasibility, and 
     timeliness of such research and for clinical outcomes 
     measures, risk adjustment, and other relevant aspects of 
     research and assessment

[[Page S6374]]

     with respect to the design of such research. Any 
     methodological standards developed and updated under this 
     subclause shall be scientifically based and include methods 
     by which new information, data, or advances in technology are 
     considered and incorporated into ongoing research projects by 
     the Institute, as appropriate. The process for developing and 
     updating such standards shall include input from relevant 
     experts, stakeholders, and decision makers, and shall provide 
     opportunities for public comment. Such standards shall also 
     include methods by which patient subpopulations can be 
     accounted for and evaluated in different types of research. 
     As appropriate, such standards shall build on existing work 
     on methodological standards for defined categories of health 
     interventions and for each of the major categories of 
     comparative effectiveness research methods (determined as of 
     the date of enactment of the Patient-Centered Outcomes 
     Research Act of 2009).
       ``(II) A translation table that is designed to provide 
     guidance and act as a reference for the Board to determine 
     research methods that are most likely to address each 
     specific comparative clinical effectiveness research 
     question.

       ``(ii) Not later than 3 years after such date, examining 
     the following:

       ``(I) Methods by which various aspects of the health care 
     delivery system (such as benefit design and performance, and 
     health services organization, management, information 
     communication, and delivery) could be assessed and compared 
     for their relative effectiveness, benefits, risks, 
     advantages, and disadvantages in a scientifically valid and 
     standardized way.
       ``(II) Methods by which efficiency and value (including the 
     full range of harms and benefits, such as quality of life) 
     could be assessed in a scientifically valid and standardized 
     way.

       ``(D) Consultation and conduct of examinations.--
       ``(i) In general.--Subject to clause (iii), in undertaking 
     the activities described in subparagraph (C), the methodology 
     committee shall--

       ``(I) consult or contract with 1 or more of the entities 
     described in clause (ii); and
       ``(II) consult with stakeholders and other entities 
     knowledgeable in relevant fields, as appropriate.

       ``(ii) Entities described.--The following entities are 
     described in this clause:

       ``(I) The Institute of Medicine of the National Academies.
       ``(II) The Agency for Healthcare Research and Quality.
       ``(III) The National Institutes of Health.
       ``(IV) Academic, non-profit, or other private entities with 
     relevant expertise.

       ``(iii) Conduct of examinations.--The methodology committee 
     shall contract with the Institute of Medicine of the National 
     Academies for the conduct of the examinations described in 
     subclauses (I) and (II) of subparagraph (C)(ii).
       ``(E) Reports.--The methodology committee shall submit 
     reports to the Board on the committee's performance of the 
     functions described in subparagraph (C). Reports submitted 
     under the preceding sentence with respect to the functions 
     described in clause (i) of such subparagraph shall contain 
     recommendations--
       ``(i) for the Institute to adopt methodological standards 
     developed and updated by the methodology committee under such 
     subparagraph; and
       ``(ii) for such other action as the methodology committee 
     determines is necessary to comply with such methodological 
     standards.
       ``(8) Providing for a peer-review process for primary 
     research.--
       ``(A) In general.--The Institute shall ensure that there is 
     a process for peer review of the research conducted under 
     paragraph (2)(A)(ii). Under such process--
       ``(i) evidence from research conducted under such paragraph 
     shall be reviewed to assess scientific integrity and 
     adherence to methodological standards adopted under paragraph 
     (10); and
       ``(ii) a list of the names of individuals contributing to 
     any peer-review process during the preceding year or years 
     shall be made public and included in annual reports in 
     accordance with paragraph (12)(D).
       ``(B) Composition.--Such peer-review process shall be 
     designed in a manner so as to avoid bias and conflicts of 
     interest on the part of the reviewers and shall be composed 
     of experts in the scientific field relevant to the research 
     under review.
       ``(C) Use of existing processes.--
       ``(i) Processes of another entity.--In the case where the 
     Institute enters into a contract or other agreement with 
     another entity for the conduct or management of research 
     under this section, the Institute may utilize the peer-review 
     process of such entity if such process meets the requirements 
     under subparagraphs (A) and (B).
       ``(ii) Processes of appropriate medical journals.--The 
     Institute may utilize the peer-review process of appropriate 
     medical journals if such process meets the requirements under 
     subparagraphs (A) and (B).
       ``(9) Dissemination of research findings.--
       ``(A) In general.--The Institute shall disseminate research 
     findings to clinicians, patients, and the general public in 
     accordance with the dissemination protocols and strategies 
     adopted under paragraph (10). Research findings 
     disseminated--
       ``(i) shall convey findings of research so that they are 
     comprehensible and useful to patients and providers in making 
     health care decisions;
       ``(ii) shall discuss findings and other considerations 
     specific to certain subpopulations, risk factors, and 
     comorbidities, as appropriate;
       ``(iii) shall include considerations such as limitations of 
     research and what further research may be needed, as 
     appropriate;
       ``(iv) shall not include practice guidelines, coverage 
     recommendations, or policy recommendations; and
       ``(v) shall not include any data the dissemination of which 
     would violate the privacy of research participants or violate 
     any confidentiality agreements made with respect to the use 
     of data under this section.
       ``(B) Dissemination protocols and strategies.--The 
     Institute shall develop protocols and strategies for the 
     appropriate dissemination of research findings in order to 
     ensure effective communication of such findings and the use 
     and incorporation of such findings into relevant activities 
     for the purpose of informing higher quality and more 
     effective and timely decisions regarding medical treatments, 
     services, and items. In developing and adopting such 
     protocols and strategies, the Institute shall consult with 
     stakeholders, including practicing clinicians and patients, 
     concerning the types of dissemination that will be most 
     useful to the end users of the information and may provide 
     for the utilization of multiple formats for conveying 
     findings to different audiences.
       ``(C) Definition of research findings.--In this paragraph, 
     the term `research findings' means the results of a study or 
     assessment.
       ``(10) Adoption.--Subject to subsection (i)(1)(A)(i), the 
     Institute shall adopt the national priorities identified 
     under paragraph (1)(A), the research project agenda 
     established under paragraph (1)(B), the methodological 
     standards developed and updated by the methodology committee 
     under paragraph (7)(C)(i), any peer-review process provided 
     under paragraph (8), and dissemination protocols and 
     strategies developed under paragraph (9)(B) by majority vote. 
     In the case where the Institute does not adopt such national 
     priorities, research project agenda, methodological 
     standards, peer-review process, or dissemination protocols 
     and strategies in accordance with the preceding sentence, the 
     national priorities, research project agenda, methodological 
     standards, peer-review process, or dissemination protocols 
     and strategies shall be referred to the appropriate staff or 
     entity within the Institute (or, in the case of the 
     methodological standards, the methodology committee) for 
     further review.
       ``(11) Coordination of research and resources and building 
     capacity for research.--
       ``(A) Coordination of research and resources.--The 
     Institute shall coordinate research conducted, commissioned, 
     or otherwise funded under this section with comparative 
     clinical effectiveness and other relevant research and 
     related efforts conducted by public and private agencies and 
     organizations in order to ensure the most efficient use of 
     the Institute's resources and that research is not duplicated 
     unnecessarily.
       ``(B) Building capacity for research.--The Institute may 
     build capacity for comparative clinical effectiveness 
     research and methodologies, including research training and 
     development of data resources (such as clinical registries), 
     through appropriate activities, including using up to 20 
     percent of the amounts appropriated or credited to the PCORTF 
     under section 9511(b) of the Internal Revenue Code of 1986 
     with respect to a fiscal year to fund extramural efforts of 
     organizations such as the Cochrane Collaboration (or a 
     successor organization) and other organizations that develop 
     and maintain a data network to collect, link, and analyze 
     data on outcomes and effectiveness from multiple sources, 
     including electronic health records.
       ``(C) Inclusion in annual reports.--The Institute shall 
     report on any coordination and capacity building conducted 
     under this paragraph in annual reports in accordance with 
     paragraph (12)(E).
       ``(12) Annual reports.--The Institute shall submit an 
     annual report to Congress and the President, and shall make 
     the annual report available to the public. Such report shall 
     contain--
       ``(A) a description of the activities conducted under this 
     section during the preceding year, including the use of 
     amounts appropriated or credited to the PCORTF under section 
     9511(b) of the Internal Revenue Code of 1986 to carry out 
     this section, research projects completed and underway, and a 
     summary of the findings of such projects;
       ``(B) the research project agenda and budget of the 
     Institute for the following year;
       ``(C) a description of research priorities identified under 
     paragraph (1)(A), dissemination protocols and strategies 
     developed by the Institute under paragraph (9)(B), and 
     methodological standards developed and updated by the 
     methodology committee under paragraph (7)(C)(i) that are 
     adopted under paragraph (10) during the preceding year;
       ``(D) the names of individuals contributing to any peer-
     review process provided under paragraph (8) during the 
     preceding year or years, in a manner such that those 
     individuals cannot be identified with a particular research 
     project; and
       ``(E) a description of efforts by the Institute under 
     paragraph (11) to--
       ``(i) coordinate the research conducted, commissioned, or 
     otherwise funded under

[[Page S6375]]

     this section and the resources of the Institute with research 
     and related efforts conducted by other private and public 
     entities; and
       ``(ii) build capacity for comparative clinical 
     effectiveness research and other relevant research and 
     related efforts through appropriate activities.
       ``(F) any other relevant information (including information 
     on the membership of the Board, expert advisory panels 
     appointed under paragraph (5), the methodology committee 
     established under paragraph (7), and the executive staff of 
     the Institute, any conflicts of interest with respect to the 
     members of such Board, expert advisory panels, and 
     methodology committee, or with respect to any individuals 
     selected for employment as executive staff of the Institute, 
     and any bylaws adopted by the Board during the preceding 
     year).
       ``(e) Administration.--
       ``(1) In general.--Subject to paragraph (2), the Board 
     shall carry out the duties of the Institute.
       ``(2) Nondelegable duties.--The activities described in 
     subsections (b)(3)(D), (d)(1), and (d)(10) are nondelegable.
       ``(f) Board of Governors.--
       ``(1) In general.--The Institute shall have a Board of 
     Governors, which shall consist of the following members:
       ``(A) The Secretary of Health and Human Services (or the 
     Secretary's designee).
       ``(B) The Director of the Agency for Healthcare Research 
     and Quality (or the Director's designee).
       ``(C) The Director of the National Institutes of Health (or 
     the Director's designee).
       ``(D) 18 members appointed by the Comptroller General of 
     the United States not later than 6 months after the date of 
     enactment of this section, as follows:
       ``(i) 3 members representing patients and health care 
     consumers.
       ``(ii) 3 members representing practicing physicians, 
     including surgeons.
       ``(iii) 3 members representing agencies that administer 
     public programs, as follows:

       ``(I) 1 member representing the Centers for Medicare & 
     Medicaid Services who has experience in administering the 
     program under title XVIII.
       ``(II) 1 member representing agencies that administer State 
     health programs (who may represent the Centers for Medicare & 
     Medicaid Services and have experience in administering the 
     program under title XIX or the program under title XXI or be 
     a governor of a State).
       ``(III) 1 member representing agencies that administer 
     other Federal health programs (such as a health program of 
     the Department of Defense under chapter 55 of title 10, 
     United States Code, the Federal employees health benefits 
     program under chapter 89 of title 5 of such Code, a health 
     program of the Department of Veterans Affairs under chapter 
     17 of title 38 of such Code, or a medical care program of the 
     Indian Health Service or of a tribal organization).

       ``(iv) 3 members representing private payers, of whom at 
     least 1 member shall represent health insurance issuers and 
     at least 1 member shall represent employers who self-insure 
     employee benefits.
       ``(v) 3 members representing pharmaceutical, device, and 
     diagnostic manufacturers or developers.
       ``(vi) 1 member representing nonprofit organizations 
     involved in health services research.
       ``(vii) 1 member representing organizations that focus on 
     quality measurement and improvement or decision support.
       ``(viii) 1 member representing independent health services 
     researchers.
       ``(2) Qualifications.--
       ``(A) Diverse representation of perspectives.--The Board 
     shall represent a broad range of perspectives and 
     collectively have scientific expertise in clinical health 
     sciences research, including epidemiology, decisions 
     sciences, health economics, and statistics.
       ``(B) Conflicts of interest.--
       ``(i) In general.--In appointing members of the Board under 
     paragraph (1)(D), the Comptroller General of the United 
     States shall take into consideration any conflicts of 
     interest of potential appointees. Any conflicts of interest 
     of members appointed to the Board under paragraph (1) shall 
     be disclosed in accordance with subsection (i)(4)(B).
       ``(ii) Recusal.--A member of the Board shall be recused 
     from participating with respect to a particular research 
     project or other matter considered by the Board in carrying 
     out its research project agenda under subsection (d)(2) in 
     the case where the member (or an immediate family member of 
     such member) has a financial or personal interest directly 
     related to the research project or the matter that could 
     affect or be affected by such participation.
       ``(3) Terms.--
       ``(A) In general.--A member of the Board appointed under 
     paragraph (1)(D) shall be appointed for a term of 6 years, 
     except with respect to the members first appointed under such 
     paragraph--
       ``(i) 6 shall be appointed for a term of 6 years;
       ``(ii) 6 shall be appointed for a term of 4 years; and
       ``(iii) 6 shall be appointed for a term of 2 years.
       ``(B) Limitation.--No individual shall be appointed to the 
     Board under paragraph (1)(D) for more than 2 terms.
       ``(C) Expiration of term.--Any member of the Board whose 
     term has expired may serve until such member's successor has 
     taken office, or until the end of the calendar year in which 
     such member's term has expired, whichever is earlier.
       ``(D) Vacancies.--
       ``(i) In general.--Any member appointed to fill a vacancy 
     prior to the expiration of the term for which such member's 
     predecessor was appointed shall be appointed for the 
     remainder of such term.
       ``(ii) Vacancies not to affect power of board.--A vacancy 
     on the Board shall not affect its powers, but shall be filled 
     in the same manner as the original appointment was made.
       ``(4) Chairperson and vice-chairperson.--
       ``(A) In general.--The Comptroller General of the United 
     States shall designate a Chairperson and Vice-Chairperson of 
     the Board from among the members of the Board appointed under 
     paragraph (1)(D).
       ``(B) Term.--The members so designated shall serve as 
     Chairperson and Vice-Chairperson of the Board for a period of 
     3 years.
       ``(5) Compensation.--
       ``(A) In general.--A member of the Board shall be entitled 
     to compensation at the per diem equivalent of the rate 
     provided for level IV of the Executive Schedule under section 
     5315 of title 5, United States Code.
       ``(B) Travel expenses.--While away from home or regular 
     place of business in the performance of duties for the Board, 
     each member of the Board may receive reasonable travel, 
     subsistence, and other necessary expenses.
       ``(6) Director and staff; experts and consultants.--The 
     Board may--
       ``(A) employ and fix the compensation of an executive 
     director and such other personnel as may be necessary to 
     carry out the duties of the Institute;
       ``(B) seek such assistance and support as may be required 
     in the performance of the duties of the Institute from 
     appropriate departments and agencies of the Federal 
     Government;
       ``(C) enter into contracts or make other arrangements and 
     make such payments as may be necessary for performance of the 
     duties of the Institute;
       ``(D) provide travel, subsistence, and per diem 
     compensation for individuals performing the duties of the 
     Institute, including members of any expert advisory panel 
     appointed under subsection (d)(5), members of the methodology 
     committee established under subsection (d)(7), and 
     individuals selected to contribute to any peer-review process 
     under subsection (d)(8); and
       ``(E) prescribe such rules, regulations, and bylaws as the 
     Board determines necessary with respect to the internal 
     organization and operation of the Institute.
       ``(7) Meetings and hearings.--The Board shall meet and hold 
     hearings at the call of the Chairperson or a majority of its 
     members. In the case where the Board is meeting on matters 
     not related to personnel, Board meetings shall be open to the 
     public and advertised through public notice at least 7 days 
     prior to the meeting.
       ``(8) Quorum.--A majority of the members of the Board shall 
     constitute a quorum for purposes of conducting the duties of 
     the Institute, but a lesser number of members may meet and 
     hold hearings.
       ``(g) Financial Oversight.--
       ``(1) Contract for audit.--The Institute shall provide for 
     the conduct of financial audits of the Institute on an annual 
     basis by a private entity with expertise in conducting 
     financial audits.
       ``(2) Review of audit and report to congress.--The 
     Comptroller General of the United States shall--
       ``(A) review the results of the audits conducted under 
     paragraph (1); and
       ``(B) submit a report to Congress containing the results of 
     such audits and review.
       ``(h) Governmental Oversight.--
       ``(1) Review and reports.--
       ``(A) In general.--The Comptroller General of the United 
     States shall review the following:
       ``(i) Processes established by the Institute, including 
     those with respect to the identification of research 
     priorities under subsection (d)(1)(A) and the conduct of 
     research projects under this section. Such review shall 
     determine whether information produced by such research 
     projects--

       ``(I) is objective and credible;
       ``(II) is produced in a manner consistent with the 
     requirements under this section; and
       ``(III) is developed through a transparent process.

       ``(ii) The overall effect of the Institute and the 
     effectiveness of activities conducted under this section, 
     including an assessment of--

       ``(I) the utilization of the findings of research conducted 
     under this section by health care decision makers; and
       ``(II) the effect of the Institute and such activities on 
     innovation and on the health economy of the United States.

       ``(B) Reports.--Not later than 5 years after the date of 
     enactment of this section, and not less frequently than every 
     5 years thereafter, the Comptroller General of the United 
     States shall submit a report to Congress containing the 
     results of the review conducted under subparagraph (A), 
     together with recommendations for such legislation and 
     administrative action as the Comptroller General determines 
     appropriate.
       ``(2) Funding assessment.--

[[Page S6376]]

       ``(A) In general.--The Comptroller General of the United 
     States shall assess the adequacy and use of funding for the 
     Institute and activities conducted under this section under 
     the PCORTF under section 9511 of the Internal Revenue Code of 
     1986. Such assessment shall include a determination as to 
     whether, based on the utilization of findings by public and 
     private payers, each of the following are appropriate sources 
     of funding for the Institute, including a determination of 
     whether such sources of funding should be continued or 
     adjusted, or whether other sources of funding not described 
     in clauses (i) through (iii) would be appropriate:
       ``(i) The transfer of funds from the Federal Hospital 
     Insurance Trust Fund under section 1817 and the Federal 
     Supplementary Medical Insurance Trust Fund under section 1841 
     to the PCORTF under section 1183.
       ``(ii) The amounts appropriated under subparagraphs (A), 
     (B), (C), (D)(ii), and (E)(ii) of subsection (b)(1) of such 
     section 9511.
       ``(iii) Private sector contributions under subparagraphs 
     (D)(i) and (E)(i) of such subsection (b)(1).
       ``(B) Report.--Not later than 8 years after the date of 
     enactment of this section, the Comptroller General of the 
     United States shall submit a report to Congress containing 
     the results of the assessment conducted under subparagraph 
     (A), together with recommendations for such legislation and 
     administrative action as the Comptroller General determines 
     appropriate.
       ``(i) Ensuring Transparency, Credibility, and Access.--The 
     Institute shall establish procedures to ensure that the 
     following requirements for ensuring transparency, 
     credibility, and access are met:
       ``(1) Public comment periods.--
       ``(A) In general.--The Institute shall provide for a public 
     comment period of not less than 45 and not more than 60 days 
     at the following times:
       ``(i) Prior to the adoption of the national priorities 
     identified under subsection (d)(1)(A), the research project 
     agenda established under subsection (d)(1)(B), the 
     methodological standards developed and updated by the 
     methodology committee under subsection (d)(7)(C)(i), the 
     peer-review process generally provided under subsection 
     (d)(8), and dissemination protocols and strategies developed 
     by the Institute under subsection (d)(9)(B) in accordance 
     with subsection (d)(10).
       ``(ii) Prior to the finalization of individual study 
     designs.
       ``(iii) After the release of draft findings with respect to 
     a systematic review and assessment of existing research and 
     evidence under subsection (d)(2)(A)(i).
       ``(B) Transmission of public comments on study design.--The 
     Institute shall transmit public comments submitted during the 
     public comment period described in subparagraph (A)(ii) to 
     the entity conducting research with respect to which the 
     individual study design is being finalized.
       ``(2) Additional forums.--The Institute shall, in addition 
     to the public comment periods described in paragraph (1)(A), 
     support forums to increase public awareness and obtain and 
     incorporate public input and feedback through media (such as 
     an Internet website) on the following:
       ``(A) The identification of research priorities, including 
     research topics, and the establishment of the research 
     project agenda under subparagraphs (A) and (B), respectively, 
     of subsection (d)(1).
       ``(B) Research findings.
       ``(C) Any other duties, activities, or processes the 
     Institute determines appropriate.
       ``(3) Public availability.--The Institute shall make 
     available to the public and disclose through the official 
     public Internet website of the Institute, and through other 
     forums and media the Institute determines appropriate, the 
     following:
       ``(A) The process and methods for the conduct of research 
     under this section, including--
       ``(i) the identity of the entity conducting such research;
       ``(ii) any links the entity has to industry (including such 
     links that are not directly tied to the particular research 
     being conducted under this section);
       ``(iii) draft study designs (including research questions 
     and the finalized study design, together with public comments 
     on such study design and responses to such comments);
       ``(iv) research protocols (including measures taken, 
     methods of research, methods of analysis, research results, 
     and such other information as the Institute determines 
     appropriate) with respect to each medical treatment, service, 
     and item described in subsection (a)(2)(B);
       ``(v) any key decisions made by the Institute and any 
     appropriate committees of the Institute;
       ``(vi) the identity of investigators conducting such 
     research and any conflicts of interest of such investigators; 
     and
       ``(vii) any progress reports the Institute determines 
     appropriate.
       ``(B) Notice of each of the public comment periods under 
     paragraph (1)(A), including deadlines for public comments for 
     such periods.
       ``(C) Public comments submitted during each of the public 
     comment periods under paragraph (1)(A), including such public 
     comments submitted on draft findings under clause (iii) of 
     such paragraph.
       ``(D) Bylaws, processes, and proceedings of the Institute, 
     to the extent practicable and as the Institute determines 
     appropriate.
       ``(E) Not later than 90 days after receipt by the Institute 
     of a relevant report or research findings, appropriate 
     information contained in such report or findings.
       ``(4) Conflicts of interest.--The Institute shall--
       ``(A) in appointing members to an expert advisory panel 
     under subsection (d)(5) and the methodology committee under 
     subsection (d)(7), and in selecting individuals to contribute 
     to any peer-review process under subsection (d)(8) and for 
     employment as executive staff of the Institute, take into 
     consideration any conflicts of interest of potential 
     appointees, participants, and staff; and
       ``(B) include a description of any such conflicts of 
     interest and conflicts of interest of Board members in the 
     annual report under subsection (d)(12), except that, in the 
     case of individuals contributing to any such peer review 
     process, such description shall be in a manner such that 
     those individuals cannot be identified with a particular 
     research project.
       ``(j) Rules.--
       ``(1) Gifts.--The Institute, or the Board and staff of the 
     Institute acting on behalf of the Institute, may not accept 
     gifts, bequeaths, or donations of services or property.
       ``(2) Establishment and prohibition on accepting outside 
     funding or contributions.--The Institute may not--
       ``(A) establish a corporation other than as provided under 
     this section; or
       ``(B) accept any funds or contributions other than as 
     provided under this part.
       ``(k) Rules of Construction.--
       ``(1) Coverage.--Nothing in this section shall be 
     construed--
       ``(A) to permit the Institute to mandate coverage, 
     reimbursement, or other policies for any public or private 
     payer; or
       ``(B) as preventing the Secretary from covering the routine 
     costs of clinical care received by an individual entitled to, 
     or enrolled for, benefits under title XVIII, XIX, or XXI in 
     the case where such individual is participating in a clinical 
     trial and such costs would otherwise be covered under such 
     title with respect to the beneficiary.
       ``(2) Reports and findings.--None of the reports submitted 
     under this section or research findings disseminated by the 
     Institute shall be construed as mandates, guidelines, or 
     recommendations for payment, coverage, or treatment.


   ``limitations on use of comparative effectiveness research by the 
                               secretary

       ``Sec. 1182.  The Secretary may only use evidence and 
     findings from comparative effectiveness research conducted 
     under section 1181 to make a determination regarding coverage 
     under title XVIII if such use is through an iterative and 
     transparent process which meets the following requirements:
       ``(1) Stakeholders and other individuals have the 
     opportunity to provide informed and relevant information with 
     respect to the determination.
       ``(2) Stakeholders and other individuals have the 
     opportunity to review draft proposals of the determination 
     and submit public comments with respect to such draft 
     proposals.
       ``(3) In making the determination, the Secretary 
     considers--
       ``(A) all other relevant evidence, studies, and research in 
     addition to such comparative effectiveness research; and
       ``(B) evidence and research that demonstrates or suggests a 
     benefit of coverage with respect to a specific subpopulation 
     of individuals, even if the evidence and findings from the 
     comparative effectiveness research demonstrates or suggests 
     that, on average, with respect to the general population the 
     benefits of coverage do not exceed the harm.


``trust fund transfers to patient-centered outcomes research trust fund

       ``Sec. 1183.  (a) In General.--The Secretary shall provide 
     for the transfer, from the Federal Hospital Insurance Trust 
     Fund under section 1817 and the Federal Supplementary Medical 
     Insurance Trust Fund under section 1841, in proportion (as 
     estimated by the Secretary) to the total expenditures during 
     such fiscal year that are made under title XVIII from the 
     respective trust fund, to the Patient-Centered Outcomes 
     Research Trust Fund (referred to in this section as the 
     `PCORTF') under section 9511 of the Internal Revenue Code of 
     1986, the following:
       ``(1) For fiscal year 2013, an amount equal to $1 
     multiplied by the average number of individuals entitled to 
     benefits under part A, or enrolled under part B, of title 
     XVIII during such fiscal year.
       ``(2) For each of fiscal years 2014, 2015, 2016, 2017, 
     2018, and 2019, an amount equal to $2 multiplied by the 
     average number of individuals entitled to benefits under part 
     A, or enrolled under part B, of title XVIII during such 
     fiscal year.
       ``(b) Adjustments for Increases in Health Care Spending.--
     In the case of any fiscal year beginning after September 30, 
     2014, the dollar amount in effect under subsection (a)(2) for 
     such fiscal year shall be equal to the sum of such dollar 
     amount for the previous fiscal year (determined after the 
     application of this subsection), plus an amount equal to the 
     product of--
       ``(1) such dollar amount for the previous fiscal year, 
     multiplied by
       ``(2) the percentage increase in the projected per capita 
     amount of National Health Expenditures from the calendar year 
     in which the previous fiscal year ends to the calendar year 
     in which the fiscal year involved ends, as most recently 
     published by the Secretary before the beginning of the fiscal 
     year.''.

[[Page S6377]]

       (b) Coordination With Provider Education and Technical 
     Assistance.--Section 1889(a) of the Social Security Act (42 
     U.S.C. 1395zz(a)) is amended by inserting ``and to enhance 
     the understanding of and utilization by providers of services 
     and suppliers of research findings disseminated by the 
     Patient-Centered Outcomes Research Institute established 
     under section 1181'' before the period at the end.
       (c) Patient-Centered Outcomes Research Trust Fund; 
     Financing for Trust Fund.--
       (1) Establishment of trust fund.--
       (A) In general.--Subchapter A of chapter 98 of the Internal 
     Revenue Code of 1986 (relating to establishment of trust 
     funds) is amended by adding at the end the following new 
     section:

     ``SEC. 9511. PATIENT-CENTERED OUTCOMES RESEARCH TRUST FUND.

       ``(a) Creation of Trust Fund.--There is established in the 
     Treasury of the United States a trust fund to be known as the 
     `Patient-Centered Outcomes Research Trust Fund' (hereafter in 
     this section referred to as the `PCORTF'), consisting of such 
     amounts as may be appropriated or credited to such Trust Fund 
     as provided in this section and section 9602(b).
       ``(b) Transfers to Fund.--
       ``(1) Appropriation.--There are hereby appropriated to the 
     Trust Fund the following:
       ``(A) For fiscal year 2010, $10,000,000.
       ``(B) For fiscal year 2011, $50,000,000.
       ``(C) For fiscal year 2012, $150,000,000.
       ``(D) For fiscal year 2013--
       ``(i) an amount equivalent to the net revenues received in 
     the Treasury from the fees imposed under subchapter B of 
     chapter 34 (relating to fees on health insurance and self-
     insured plans) for such fiscal year; and
       ``(ii) $150,000,000.

       ``(E) For each of fiscal years 2014, 2015, 2016, 2017, 
     2018, and 2019--
       ``(i) an amount equivalent to the net revenues received in 
     the Treasury from the fees imposed under subchapter B of 
     chapter 34 (relating to fees on health insurance and self-
     insured plans) for such fiscal year; and
       ``(ii) $150,000,000.
     The amounts appropriated under subparagraphs (A), (B), (C), 
     (D)(ii), and (E)(ii) shall be transferred from the general 
     fund of the Treasury, from funds not otherwise appropriated.
       ``(2) Trust fund transfers.--In addition to the amounts 
     appropriated under paragraph (1), there shall be credited to 
     the PCORTF the amounts transferred under section 1183 of the 
     Social Security Act.
       ``(3) American recovery and reinvestment funds.--In 
     addition to the amounts appropriated under paragraph (1) and 
     the amounts credited under paragraph (2), of amounts 
     appropriated for comparative effectiveness research to be 
     allocated at the discretion of the Secretary of Health and 
     Human Services under the heading Agency for Healthcare 
     Research and Quality under the heading Department of Health 
     and Human Services under title VIII of Division A of the 
     American Recovery and Reinvestment Act of 2009 (Public Law 
     111-5), $10,000,000 shall be transferred to the Trust Fund.
       ``(4) Limitation on transfers to pcortf.--No amount may be 
     appropriated or transferred to the PCORTF on and after the 
     date of any expenditure from the PCORTF which is not an 
     expenditure permitted under this section. The determination 
     of whether an expenditure is so permitted shall be made 
     without regard to--
       ``(A) any provision of law which is not contained or 
     referenced in this chapter or in a revenue Act, and
       ``(B) whether such provision of law is a subsequently 
     enacted provision or directly or indirectly seeks to waive 
     the application of this paragraph.
       ``(c) Trustee.--The Secretary of Health and Human Services 
     shall be a trustee of the PCORTF.
       ``(d) Expenditures From Fund.--Amounts in the PCORTF are 
     available, without further appropriation, to the Patient-
     Centered Outcomes Research Institute established by section 
     2(a) of the Patient-Centered Outcomes Research Act of 2009 
     for carrying out part D of title XI of the Social Security 
     Act (as in effect on the date of enactment of the Patient-
     Centered Outcomes Research Act of 2009).
       ``(e) Net Revenues.--For purposes of this section, the term 
     `net revenues' means the amount estimated by the Secretary of 
     the Treasury based on the excess of--
       ``(1) the fees received in the Treasury under subchapter B 
     of chapter 34, over
       ``(2) the decrease in the tax imposed by chapter 1 
     resulting from the fees imposed by such subchapter.
       ``(f) Termination.--No amounts shall be available for 
     expenditure from the PCORTF after September 30, 2019, and any 
     amounts in such Trust Fund after such date shall be 
     transferred to the general fund of the Treasury.''.
       (B) Clerical amendment.--The table of sections for 
     subchapter A of chapter 98 of such Code is amended by adding 
     at the end the following new item:

``Sec. 9511. Patient-Centered Outcomes Research Trust Fund.''.

       (2) Financing for fund from fees on insured and self-
     insured health plans.--
       (A) General rule.--Chapter 34 of the Internal Revenue Code 
     of 1986 is amended by adding at the end the following new 
     subchapter:

         ``Subchapter B--Insured and Self-Insured Health Plans

``Sec. 4375. Health insurance.
``Sec. 4376. Self-insured health plans.
``Sec. 4377. Definitions and special rules.

     ``SEC. 4375. HEALTH INSURANCE.

       ``(a) Imposition of Fee.--There is hereby imposed on each 
     specified health insurance policy for each policy year ending 
     after September 30, 2012, a fee equal to the product of $2 
     ($1 in the case of policy years ending during fiscal year 
     2013) multiplied by the average number of lives covered under 
     the policy.
       ``(b) Liability for Fee.--The fee imposed by subsection (a) 
     shall be paid by the issuer of the policy.
       ``(c) Specified Health Insurance Policy.--For purposes of 
     this section:
       ``(1) In general.--Except as otherwise provided in this 
     section, the term `specified health insurance policy' means 
     any accident or health insurance policy (including a policy 
     under a group health plan) issued with respect to individuals 
     residing in the United States.
       ``(2) Exemption for certain policies.--The term `specified 
     health insurance policy' does not include any insurance if 
     substantially all of its coverage is of excepted benefits 
     described in section 9832(c).
       ``(3) Treatment of prepaid health coverage arrangements.--
       ``(A) In general.--In the case of any arrangement described 
     in subparagraph (B)--
       ``(i) such arrangement shall be treated as a specified 
     health insurance policy, and
       ``(ii) the person referred to in such subparagraph shall be 
     treated as the issuer.
       ``(B) Description of arrangements.--An arrangement is 
     described in this subparagraph if under such arrangement 
     fixed payments or premiums are received as consideration for 
     any person's agreement to provide or arrange for the 
     provision of accident or health coverage to residents of the 
     United States, regardless of how such coverage is provided or 
     arranged to be provided.
       ``(d) Adjustments for Increases in Health Care Spending.--
     In the case of any policy year ending in any fiscal year 
     beginning after September 30, 2014, the dollar amount in 
     effect under subsection (a) for such policy year shall be 
     equal to the sum of such dollar amount for policy years 
     ending in the previous fiscal year (determined after the 
     application of this subsection), plus an amount equal to the 
     product of--
       ``(1) such dollar amount for policy years ending in the 
     previous fiscal year, multiplied by
       ``(2) the percentage increase in the projected per capita 
     amount of National Health Expenditures from the calendar year 
     in which the previous fiscal year ends to the calendar year 
     in which the fiscal year involved ends, as most recently 
     published by the Secretary of Health and Human Services 
     before the beginning of the fiscal year.
       ``(e) Termination.--This section shall not apply to policy 
     years ending after September 30, 2019.

     ``SEC. 4376. SELF-INSURED HEALTH PLANS.

       ``(a) Imposition of Fee.--In the case of any applicable 
     self-insured health plan for each plan year ending after 
     September 30, 2012, there is hereby imposed a fee equal to $2 
     ($1 in the case of plan years ending during fiscal year 2013) 
     multiplied by the average number of lives covered under the 
     plan.
       ``(b) Liability for Fee.--
       ``(1) In general.--The fee imposed by subsection (a) shall 
     be paid by the plan sponsor.
       ``(2) Plan sponsor.--For purposes of paragraph (1) the term 
     `plan sponsor' means--
       ``(A) the employer in the case of a plan established or 
     maintained by a single employer,
       ``(B) the employee organization in the case of a plan 
     established or maintained by an employee organization,
       ``(C) in the case of--
       ``(i) a plan established or maintained by 2 or more 
     employers or jointly by 1 or more employers and 1 or more 
     employee organizations,
       ``(ii) a multiple employer welfare arrangement, or
       ``(iii) a voluntary employees' beneficiary association 
     described in section 501(c)(9),

     the association, committee, joint board of trustees, or other 
     similar group of representatives of the parties who establish 
     or maintain the plan, or
       ``(D) the cooperative or association described in 
     subsection (c)(2)(F) in the case of a plan established or 
     maintained by such a cooperative or association.
       ``(c) Applicable Self-Insured Health Plan.--For purposes of 
     this section, the term `applicable self-insured health plan' 
     means any plan for providing accident or health coverage if--
       ``(1) any portion of such coverage is provided other than 
     through an insurance policy, and
       ``(2) such plan is established or maintained--
       ``(A) by one or more employers for the benefit of their 
     employees or former employees,
       ``(B) by one or more employee organizations for the benefit 
     of their members or former members,
       ``(C) jointly by 1 or more employers and 1 or more employee 
     organizations for the benefit of employees or former 
     employees,
       ``(D) by a voluntary employees' beneficiary association 
     described in section 501(c)(9),
       ``(E) by any organization described in section 501(c)(6), 
     or
       ``(F) in the case of a plan not described in the preceding 
     subparagraphs, by a multiple

[[Page S6378]]

     employer welfare arrangement (as defined in section 3(40) of 
     Employee Retirement Income Security Act of 1974), a rural 
     electric cooperative (as defined in section 3(40)(B)(iv) of 
     such Act), or a rural telephone cooperative association (as 
     defined in section 3(40)(B)(v) of such Act).
       ``(d) Adjustments for Increases in Health Care Spending.--
     In the case of any plan year ending in any fiscal year 
     beginning after September 30, 2014, the dollar amount in 
     effect under subsection (a) for such plan year shall be equal 
     to the sum of such dollar amount for plan years ending in the 
     previous fiscal year (determined after the application of 
     this subsection), plus an amount equal to the product of--
       ``(1) such dollar amount for plan years ending in the 
     previous fiscal year, multiplied by
       ``(2) the percentage increase in the projected per capita 
     amount of National Health Expenditures from the calendar year 
     in which the previous fiscal year ends to the calendar year 
     in which the fiscal year involved ends, as most recently 
     published by the Secretary of Health and Human Services 
     before the beginning of the fiscal year.
       ``(e) Termination.--This section shall not apply to plan 
     years ending after September 30, 2019.

     ``SEC. 4377. DEFINITIONS AND SPECIAL RULES.

       ``(a) Definitions.--For purposes of this subchapter--
       ``(1) Accident and health coverage.--The term `accident and 
     health coverage' means any coverage which, if provided by an 
     insurance policy, would cause such policy to be a specified 
     health insurance policy (as defined in section 4375(c)).
       ``(2) Insurance policy.--The term `insurance policy' means 
     any policy or other instrument whereby a contract of 
     insurance is issued, renewed, or extended.
       ``(3) United states.--The term `United States' includes any 
     possession of the United States.
       ``(b) Treatment of Governmental Entities.--
       ``(1) In general.--For purposes of this subchapter--
       ``(A) the term `person' includes any governmental entity, 
     and
       ``(B) notwithstanding any other law or rule of law, 
     governmental entities shall not be exempt from the fees 
     imposed by this subchapter except as provided in paragraph 
     (2).
       ``(2) Treatment of exempt governmental programs.--In the 
     case of an exempt governmental program, no fee shall be 
     imposed under section 4375 or section 4376 on any covered 
     life under such program.
       ``(3) Exempt governmental program defined.--For purposes of 
     this subchapter, the term `exempt governmental program' 
     means--
       ``(A) any insurance program established under title XVIII 
     of the Social Security Act,
       ``(B) the medical assistance program established by title 
     XIX or XXI of the Social Security Act,
       ``(C) any program established by Federal law for providing 
     medical care (other than through insurance policies) to 
     individuals (or the spouses and dependents thereof) by reason 
     of such individuals being--
       ``(i) members of the Armed Forces of the United States, or
       ``(ii) veterans, and
       ``(D) any program established by Federal law for providing 
     medical care (other than through insurance policies) to 
     members of Indian tribes (as defined in section 4(d) of the 
     Indian Health Care Improvement Act).
       ``(c) Treatment as Tax.--For purposes of subtitle F, the 
     fees imposed by this subchapter shall be treated as if they 
     were taxes.
       ``(d) No Cover Over to Possessions.--Notwithstanding any 
     other provision of law, no amount collected under this 
     subchapter shall be covered over to any possession of the 
     United States.''.
       (B) Clerical amendments.--
       (i) Chapter 34 of such Code is amended by striking the 
     chapter heading and inserting the following:

           ``CHAPTER 34--TAXES ON CERTAIN INSURANCE POLICIES

          ``subchapter a. policies issued by foreign insurers

         ``subchapter b. insured and self-insured health plans

         ``Subchapter A--Policies Issued By Foreign Insurers''.

       (ii) The table of chapters for subtitle D of such Code is 
     amended by striking the item relating to chapter 34 and 
     inserting the following new item:

          ``Chapter 34--Taxes on Certain Insurance Policies''.

     SEC. 3. COORDINATION WITH FEDERAL COORDINATING COUNCIL FOR 
                   COMPARATIVE EFFECTIVENESS RESEARCH.

       Section 804 of Division A of the American Recovery and 
     Reinvestment Act of 2009 (42 U.S.C. 299b-8) is amended--
       (1) in subsection (c)--
       (A) in paragraph (1), by striking ``and'' at the end;
       (B) in paragraph (2), by striking the period at the end and 
     inserting ``; and''; and
       (C) by adding at the end the following new paragraph:
       ``(3) provide support to the Patient-Centered Outcomes 
     Research Institute established under section 1181(b)(1) of 
     the Social Security Act (referred to in this section as the 
     `Institute').'';
       (2) in subsection (d)(2)--
       (A) by redesignating subparagraph (B) as subparagraph (C); 
     and
       (B) by inserting after subparagraph (A) the following new 
     subparagraph:
       ``(B) Inclusion of chairperson of the board of governors of 
     the patient-centered outcomes research institute.--In the 
     case where the Chairperson of the Board of Governors of the 
     Patient-Centered Outcomes Research Institute established 
     under section 1181(f) of the Social Security Act is a senior 
     Federal officer or employee with responsibility for a health-
     related program, the members of the council shall include 
     such Chairperson.''.
       (3) in subsection (e)(2), by striking ``regarding its 
     activities'' and all that follows through the period at the 
     end and inserting ``containing--
       ``(A) an inventory of its activities with respect to 
     comparative effectiveness research conducted by relevant 
     Federal departments and agencies; and
       ``(B) recommendations concerning better coordination of 
     comparative effectiveness research by such departments and 
     agencies.'';
       (4) by redesignating subsection (g) as subsection (h); and
       (5) by inserting after subsection (f) the following new 
     subsection:
       ``(g) Coordination With the Patient-Centered Outcomes 
     Research Institute.--The Council shall coordinate with the 
     Institute in carrying out its duties under this section.''.

     SEC. 4. GAO REPORT ON NATIONAL COVERAGE DETERMINATIONS 
                   PROCESS.

       Not later than 18 months after the date of enactment of 
     this Act, the Comptroller General of the United States shall 
     submit a report to Congress on the process for making 
     national coverage determinations (as defined in section 
     1869(f)(1)(B) of the Social Security Act (42 U.S.C. 
     1395ff(f)(1)(B)) under the Medicare program under title XVIII 
     of the Social Security Act. Such report shall include a 
     determination whether, in initiating and conducting such 
     process, the Secretary of Health and Human Services has 
     complied with applicable law and regulations, including 
     requirements for consultation with appropriate outside 
     experts, providing appropriate notice and comment 
     opportunities to the public, and making information and data 
     (other than proprietary data) considered in making such 
     determinations available to the public and to nonvoting 
     members of any advisory committees established to advise the 
     Secretary with respect to such determinations.

  Mr. CONRAD. Mr. President, today I join my good friend and colleague, 
Senator Baucus, in introducing the Patient-Centered Outcomes Research 
Act of 2009. This proposal builds on the legislation we introduced 
during the last Congress. Our legislation is the product of months of 
careful deliberations regarding the best way to expand the quality and 
quantity of evidence available to patients, physicians, and other 
health care decision-makers about the comparative clinical 
effectiveness of health care services and treatments. We have met with 
dozens of key stakeholders and thought leaders to discuss various 
aspects of this legislation. People have come to us with many 
constructive suggestions, many of which are reflected in the bill that 
we are introducing today. I am proud of the result. This legislation 
lays the groundwork for improving health care quality and patient 
outcomes, enhancing patient safety, and reducing overall health care 
costs in the long run.
  As Chairman of the Senate Budget Committee, I am acutely aware of the 
long-term budget challenges facing our Nation. Health care spending is 
growing at an unsustainable rate. Although demographic changes 
associated with the retirement of the baby boom generation contribute 
to this spending growth, the most significant factor is growth in 
health care costs in excess of per capita GDP growth. According to 
Congressional Budget Office projections, by 2050, Medicare and Medicaid 
spending alone will consume 12 percent of our Nation's gross domestic 
product.
  But excess growth in per capita health care costs is not just a 
challenge for Federal health spending and the Federal budget. If we 
continue on the current trajectory, the private sector will also be 
overwhelmed by rising health care costs. In fact, total health care 
spending is projected to grow from about 17.6 percent of GDP in 2009--
which is far higher than in other industrialized countries--to more 
than 37 percent of GDP in 2050.
  Clearly, we need to address the underlying causes of rising health 
care costs, not just in the Medicare and Medicaid programs, but in the 
overall health care system. Simply cutting Medicare and Medicaid 
without making other changes will do little to solve the larger problem 
we face. Skyrocketing health care costs are hurting families, 
businesses, and State and Federal budgets. In a speech before the

[[Page S6379]]

Business Roundtable on March 12th, President Obama emphasized this 
point: ``Medicare costs are consuming our Federal budget. Medicaid is 
overwhelming our State budgets. At the fiscal summit we held in the 
White House a few weeks ago, the one thing on which everyone agreed was 
that the greatest threat to America's fiscal health is not the 
investments we've made to rescue our economy. It is the skyrocketing 
cost of our health care system.''
  Health care reform is about achieving three important goals: choice, 
quality, and affordability. To achieve these three goals, we must 
confront the fact that our health care system does not deliver care as 
effectively or efficiently as it should. There is widespread agreement 
that Americans are not getting good value for the money we are already 
spending on health care. According to work by the Dartmouth Atlas 
Project, nearly 30 percent of total spending in our health care system, 
or $700 billion per year, is wasteful and does nothing to improve 
health outcomes.
  Despite our high level of health care spending, health outcomes in 
the United States are no better than health outcomes in the other OECD 
countries. Indeed, the U.S. spends twice as much as other OECD nations 
on health care, yet Americans have shorter average life expectancies 
and higher average mortality rates than residents of other OECD 
countries. OECD data show that the U.S. has one of the highest rates of 
medical errors among industrialized nations and that U.S. patients are 
more likely to receive duplicate tests and more likely to visit an 
emergency room for a condition that could have been treated in a 
regular office visit than most other nations in the comparison. 
Similarly, a 2008 Commonwealth Fund report found that the U.S. is last 
among 19 industrialized nations in preventable mortality, or deaths 
that could have been prevented if individuals had access to timely and 
effective care.
  We can and must find ways to deliver health care more efficiently, 
reduce ineffective or unnecessary care, and get better health outcomes 
without harming patients.
  One solution is to generate better information about the relative 
clinical effectiveness of alternative health strategies--and encourage 
patients and providers to use that information to make better choices 
about their health. Many health care services and treatments are 
absorbed quickly into routine medical care--yet there is little 
evidence that these services and treatments are any more clinically 
effective than existing treatments and services. Generating more 
comparative clinical effectiveness research is one of the keys to 
transforming our health care system away from a system based on volume 
toward a system that focuses on evidence-based medicine and improving 
patient outcomes.
  The Federal Government currently funds some comparative effectiveness 
research through the Agency for Healthcare Research and Quality, AHRQ, 
the National Institutes of Health, NIH, and the Veterans Health 
Administration. For example, the Effective Health Care Program at AHRQ 
has been a successful initiative. But comparative effectiveness 
research is not the primary focus of any Federal agency--nor is this 
Federal funding occurring permanently on a large scale.
  Provisions included in the American Recovery and Reinvestment Act, 
ARRA, temporarily expanded existing Federal efforts by providing $1.1 
billion to AHRQ, NIH, and the Secretary of Health and Human Services, 
HHS, for such research through 2010. Important work is currently 
underway to develop recommendations for how best to utilize some of 
these resources. In particular, I would like to commend the work being 
done by the Institutes of Medicine, IOM, to convene a panel of experts 
that is tasked with making recommendations on how to spend the $400 
million provided to the HHS Secretary through ARRA. The IOM panel has 
been doing extraordinary work in gathering ideas and input from a very 
broad group of stakeholders under a very tight timeline. I look forward 
to seeing the results of its work at the end of the month. It is this 
model of allowing for input from a broad set of stakeholders and of 
conducting priority-setting activities in a transparent way that we are 
hoping to advance in the legislation we are introducing today.
  The Congressional Budget Office, CBO, the Medicare Payment Advisory 
Commission, MedPAC, and the IOM have all discussed the positive impact 
of creating a new entity charged solely with conducting research on the 
comparative effectiveness of health interventions, including 
pharmaceuticals, medical devices, medical procedures, diagnostic tools, 
medical services and other therapies.
  In its June 2007 report to Congress, MedPAC issued a unanimous 
recommendation that ``Congress should charge an independent entity to 
sponsor credible research on comparative effectiveness of health care 
services and disseminate this information to patients, providers, and 
public and private payers.''

  And the Congressional Budget Office agrees. In a report, entitled, 
``Research on the Comparative Effectiveness of Medical Treatments: 
Issues and Options for an Expanded Federal Role,'' former CBO Director 
Peter Orszag wrote that, ``generating better information about the 
costs and benefits of different treatment options--through research on 
the comparative effectiveness of those options--could help reduce 
health care spending without adversely affecting health overall.''
  The IOM also supports getting better information into the hands of 
patients and providers. As part of its report, ``Learning What Works 
Best: The Nation's Need for Evidence on Comparative Effectiveness in 
Health Care,'' the Institute concluded that, ``[a] substantially 
increased capacity to conduct and evaluate research on clinical 
effectiveness of interventions brings many potential opportunities for 
improvement across a wide spectrum of healthcare needs.''
  This bill that Senator Baucus and I are introducing today represents 
an important step in creating a long-term vision for expanding 
comparative clinical effectiveness research. The bill would 
significantly expand the conduct of comparative clinical effectiveness 
research to get better information into the hands of patients and 
providers in the hopes of improving health outcomes and reducing 
unnecessary or ineffective care.
  The purpose of this bill is to provide patients and physicians with 
objective and credible evidence about which health care treatments and 
services are most clinically effective for particular patient 
populations. The research conducted under our bill would evaluate and 
compare the clinical effectiveness of two or more health care 
interventions, protocols for treatment, care management, and delivery, 
procedures, medical devices, diagnostic tools, and pharmaceutical, 
including biologicals
  Access to better evidence about what works best will help patients 
and health care providers make better-informed decisions about how best 
to treat particular diseases and conditions. Our hope is that the 
evidence generated by this research could lead to savings in the 
overall health care system over the long-term by empowering patients 
and doctors with information about treatments and services that may be 
clinically ineffective, while at the same time improving health care 
outcomes and quality.
  Specifically, our bill creates a private, nonprofit corporation, 
known as the Patient-Centered Outcomes Research Institute, which would 
be responsible setting national research priorities and carrying out a 
comparative clinical effectiveness research agenda. In conducting the 
research, the Institute would contract with AHRQ, the VA, and other 
appropriate public and private entities and could use a variety of 
research methods, including clinical trials, observational studies and 
systematic reviews of existing evidence.
  Many leading experts on this issue, such as MedPAC, have concerns 
that a large entity within the Federal government would be vulnerable 
to political interference that could hamper the Institute's 
credibility, and, therefore, limit the usefulness of its research. As a 
result, we chose a model outside of the Federal government, but subject 
to government oversight.
  In order to ensure that the information developed is credible and 
unbiased, our bill establishes a 21-Member Board of Governors to 
oversee the Institute's activities. Permanent board members would 
include the HHS Secretary and

[[Page S6380]]

the Directors of AHRQ and NIH. The remaining 18 board members would be 
appointed by the Comptroller General of the U.S. and would include a 
balanced mix of patients, physicians, public and private payers, 
academic researchers, philanthropic organizations, quality improvement 
entities, and medical technology manufacturers.

  To ensure further credibility, the Institute is also required to 
appoint expert advisory panels of patients, clinicians, researchers and 
other stakeholders that would assist in the development and carrying 
out of the research agenda; establish a methodology committee that 
would help create methodological standards by which all research 
commissioned by the Institute must be conducted; create a peer review 
process through which all primary research findings must be assessed; 
and develop protocols to help translate and disseminate the evidence in 
the most effective, user-friendly way.
  Moreover, Senator Baucus and I want to ensure that the operations of 
the Institute are transparent and focused on the needs of patients. 
Therefore, we built in a strong role for public comment prior to all 
key decisions made by the Institute. For example, the bill requires 
public comment periods prior to the approval of research priorities and 
individual study designs. In addition, the bill calls for public forums 
to seek input, requires that all proceedings of the Institute be made 
public at least seven days in advance and be made available through 
annual reports, and requires that any conflicts of interest be made 
public and that board members recuse themselves from matters in which 
they have a financial or personal interest.
  Because all health care users will benefit from this research, our 
legislation funds the Institute with contributions from both public and 
private payers. These contributions will include mandatory general 
revenues from the Federal Government, amounts from the Medicare Trust 
Funds equal to $2 per beneficiary annually, and amounts from a $2 fee 
per-covered life assessed annually on insured and self-insured health 
plans. Funding will ramp up over a series of years. By the 5th year, we 
expect the Institute's total annual funding to reach nearly $600 
million per year and continue to grow thereafter.
  The concept of an all-payer approach for comparative effectiveness 
research has been embraced by a number of health care experts. For 
example, on the subject of comparative effectiveness information in its 
June 2008 report, MedPAC stated: ``The Commission supports funding from 
federal and private sources as the research findings will benefit all 
users--patients, providers, private health plans, and federal health 
programs. The Commission also supports a dedicated funding mechanism to 
help ensure the entity's independence and stability. Dedicated broadly 
based financing would reduce the likelihood of outside influence and 
would best ensure the entity's stability . . .''
  To ensure accountability for these funds and to the Institute's 
mission, our bill requires an annual financial audit of the Institute. 
In addition, the bill requires GAO to report to Congress every five 
years on the processes developed by the Institute and its overall 
effectiveness, including how the research findings are used by health 
care consumers and what impact the research is having on the health 
economy. Finally, the bill requires a review of the adequacy of the 
Institute's funding, which will include a review of the appropriateness 
and adequacy of each funding source.
  Let me take a moment to address some of the criticisms that might be 
levied against this proposal. Some may say this Institute will impede 
access to care and will deny coverage for high-cost health care 
services. That is simply not the case. Our proposal explicitly 
prohibits the Institute from making coverage decisions or setting 
practice guidelines. It will be up to medical societies and patient 
groups to use the research findings as they see fit. Moreover, to the 
extent that high-cost health care services or new technologies are 
studied by the Institute and found to be clinically ineffective 
compared to other services and technologies, such evidence will be made 
public to consumers and providers so that they can make informed 
choices.

  We have been working with colleagues on the other side of the aisle 
who have concerns about the impact this research could have on patient 
safety and access to health care treatments and services. For several 
months, we have been engaged in an active dialogue to address these 
concerns. While I am disappointed that those discussions did not result 
in co-sponsorships for this legislation at this time, I look forward to 
continuing that dialogue in a constructive manner as we work to include 
a long-term vision for comparative effectiveness research in a 
comprehensive health reform bill.
  In the meantime, we have made a number of meaningful changes to our 
legislation that address the concerns voiced by our colleagues. For 
example, we have placed a greater focus on aspects of personalized 
medicine and included new patient safeguards to ensure that when CMS 
uses this research it does so through a process that is transparent, 
allows for public comment, and takes into account the benefits to 
particular subpopulations.
  This bill is a balanced, carefully crafted proposal that has taken 
into consideration the recommendations of a broad range of stakeholders 
and thought-leaders. We welcome further discussion and suggested 
improvements. But we refuse to allow this proposal to get bogged down 
in political maneuvering or scare tactics. Our nation needs to 
immediately ramp up and sustain a major comparative clinical 
effectiveness research initiative to improve health outcomes and reduce 
ineffective and inefficient care.
  Senator Baucus and I will work jointly to push for the expeditious 
enactment of this bill as part of a comprehensive health reform bill. I 
urge all of my colleagues to join our effort and cosponsor the Patient-
Centered Outcomes Research Act of 2009. There is no time to waste.
                                 ______